like other said, if phase 3 passes, they will get another 90m from the warrants, and probably dilute further say, another 20m shares at $20 bucks for 400m. not too shabby eh? it all depends on phase 3 results.
there isn't many company with so much potential than THLD. TWO phase III trials in couple of months.
quick math says, this should be in the 30's if both are approved. $2.5 billion market cap for company that has STS and pancreatic cancer is very very very doable, especially if it is pro-drug. Other indications (Lung, Brain, MM, skin) will dance around investors head once the first indication STS or PaCa has good data.
time for selling at top and buying back will be harder and harder from here due to limited time we have. I think we have seen the last of the 3s and probably go to 5s in a months and then 7s by November and then quickly shoot to double digits a week b4 data is released.
Hey guys, i don't recall what our drug would sell for if approved for STS or PaCa. Also, does our orphan designation allow TH-302 (Evofosfamide) to command much higher price in all indication?
just read it.. seems though most articles are saying 1st Q 2016 when CEO said in the last two conference end of the year. nevertheless, i agree with article that it will run up soon.
thanks for bringing it up.. yea i read numerious studies where age makes a difference. so for STS its 50+. For Pancreatic cancer, its 60+ from one of the studies i read up on. Our Pancreatic trial favored the control arm on age. but all group had age of 60+ so you can discount that data.
STS on paper looks fantastic.. lets hope phase III data shows the same rate as in Phase II and EORTC control group. Crossing fingers here.
I have a feeling both data will be released sometimes in Nov or dec.. we'll see.
keep in mind that Picasso trial age was 63 .. so that goes that.. but overall age does heavily favor the TH302 on STS over dox's EORTC data. here is to successful STS trial!
When i first bought the stock 1.5 years ago, i thought both trials was a slam dunk. HOwever, after extensive DD, of course you find faults here and there. There are many cons and pros if you break down the Phase II data on Pancreatic Cancer. Brief + and -s.
- control group was older, sicker, had more metastasis, and OS crossover really killed the OS data.
- PFS was not independently verified as far as i know.
- Bias could be introduced since it was open labeled or was this STS... confused.
- Need to beat out Abraxane of 2.1 months.
- nice sample size for phase II. this gives our phase III more chance of repeating the Phase II.
- PFS and OS for those who crossover seems very solid. more converted to PR.. very solid.
- 340 group was better than 240 group although 340 group was sicker and older. (Control was oldest and sickest)
- very quickly recruited, ahead of schedule.. you don't see this often.. good omen imo.
bottom line, i give PaCa better odds than coin toss of STS.. perhaps 70%.
if STS comes out positive, i think PaCa will come out positive 95% and vice versa. Imagine the future indication of this prodrug if it works on both trials. Lung, brain, skin, MM, prostate, etc... $100 easy in few years imo if all goes well.
im willing to risk half of my holding through the data (of course this can change depending on what side of bed i wake up lol)
This is what we need to get a positive data from our STS phase 3 trial:
10m vs 12.1m
11m vs 13.3m
12m vs 14.5m
13m vs 15.8m
14m vs 17.0m
15m vs 18.2m
16m vs 19.4m
17m vs 20.6m
18m vs 21.8m
rough idea where we need to be to be successful. TH-302 + Dox will be the standard of care for STS if we hit any of the points mentioned above.
AS you guys already know, our phase 2 data of Soft Tissue Sarcoma (STS) was done without control arm. Best we can compare it is to the EORTC 62012 which studied Doxorubicin vs Doxorubicin + Ifosfamide.
I will use the Doxurbicin data from the EORTC to draw comparison. Keep in mind that most of the enrollement criteria was nearly identical except EORTC age limit was 60. Note that no low grade tumor was accepted. Also to note is that the Picasso Trial phase 3 trial also had doxorubicin as control arm their OS was 16.9 months, but they accepted low grade tumors, thus probably added couple of months imo.
EORTC sample size for Doxorubicin: n= 228, our Phase II for Dox+Evo: n=91
EORTC median age: 48. Ours: 57
EORTC performance Status: 0 - 57%. 1 - 43%. Ours: 0 - 45%, 1 - 55%
EORTC Lung metastatic: 65%, ours: 69%. Liver metastatic: 17%, ours: 18%
EORTC PFS: 4.6 months, Ours: 6.7 months
EORTC OS: 12.8months, Ours: 21.5 months
Picasso trial OS for Dox: 16.9 months.
However all this said, there is common belief standard of care has gone up recently and should add couple of months of OS from the EORTC data, which was ran from 2003 to 2012. Also keep in mind most of sites of EORTC was in Europe, while ours is global.
Comparing them we should be good for STS, but as you might already know, our interim data didn't stop for efficasy, thus we can rule out 12.8 months vs 21.5 months. I think it will be a close call when data comes out. Im personally thinking OS of Dox from 14 to 16 months, and our from 17 to 19. So I give it a rougly coin toss whether we make it or not.
i think they originally thought they can use the imaging unit to better target patient population... to find out who has more hypoxic area in the tumor and thus would be more effective on TH-302. That said, they probably dumped it since that would require new expensive studies andd implicate use of th-302 to a limited population. I always wondered why they even started the program.
basically most pancreatic studies are hypoxic by nature thus woudln't need this device.. it would just be too complicated. In another words, more requirements = less use for th-302 = less use of th302 in the long term. I bet merck said to drop it lol.
Perhaps management was thinking they can sell this machine to major hospital thus equal more revenue at first, but did the calculations and probably thought it wasn't worth the trouble.
only my opinion. don't even know if it made any sense.
- Phase III trial data on Soft Tissue Sarcoma, end of year
- Phase III trial data on Pancreatic Cancer, end of year
- stock relatively very low with just over 300m in market cap.
- potential to be in the billions and billions.
- Phase II (440 people, large enough to apply for approval) in Lung Cancer, recruiting right now, and data slated for 2017, which can easily add another billion per year in sales.
- Merck KGAA is partnered on Pancreatic world wide, and THLD can co-commercialize in USA.
- Soft Tissue Sarcoma, 100 percent not partnered (contrary to what people believe) with Merck.
- TH-4000, our next hypoxia triggered prodrug will start Phase II very soon (probably in a month)
- Multiple Phase 1/2 on TH-302 including brain, skin, mulitiple myloma, etc.
- plenty of cash (80m at end of 1st Q, ending in March 31st)
Towards end of year, this has pretty good chance to be multi bagger, maybe even 10 bagger in a year.
GL hold and get rewarded.
hey man this is what makes a market.. if no one sold, this would be $10000 per share seriously. if no one sold that is. Im an old fart with money to spare, hence i do what i do and this works for me. I have too many shares to mention.
all this said, im betting that release of Two phase III data at the end of the year is too good to pass up and i suspect traders and their mama will buy this once momo hits. many many articles will be written (both good and bad) towards end of the year. Im sure you'll make money, and im betting i will just by holding here. You never know.. Merck might just buy this outright tomorrow for all we know!
I have DDed this to death, and im pretty sure TH-302 works! just how well is the question. Look at all of the previous data including monotherapy, crossover data, pfs, and you too will know that this works.
anyways, good luck with your trading. once you have enough $$$$ down the road, you'll see that long term holding works best.
still haven't decided what to do on the eventual run-up vs holding. I wish i knew what data will come out first. Man imagine if we get a surprise positive data on both at the same time! oh the dram...
True.. but end of the year was announced at last CC as well. Remember that STS was delayed a good 6 months from the original mid 2015. you know how delayed trial usual end up right? croxxing fingers here. HOwever that said, it seems our pancreatic cancer is on-time and perhaps even a bit early. That is very good sign imo.
Lets hope it beats abraxane OS of 2.1 months. if it beats, it will become standard care for PaCancer.
everything that needed to be said has been said. we are all just waiting for the TWO phase III trial end of the year. It will definitely be fun.
i just listened to the CC.. nothing new. exactly same as b4.